Clinical Trial of Topical ABL01 Treatment of Onychomycosis

NCT03141840 | Completed

• 1 other identifier: AB001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.

Conditions

Onychomycosis of Toenail

Outcome Measures

Primary Outcomes (1)

• Number of study subjects with a reduction in infected nail area at 6 months.

  Clinical improvement of the condition is assessed by analyzing changes in infected nail area (in relation to total nail area) due to ABL01 or placebo treatment. Clinical improvement is considered to be a 40% reduction in infected area at the 6 month time period.

  6 months

Secondary Outcomes (5)

• Questionnaire regarding subjects opinion of the treatment, nail improvement.

  12 months

• Questionnaire regarding subjects opinion of the treatment, ease of use.

  12 months

• Number of study subjects with treatment-related adverse events

  12 months

• Number of study subjects with a reduction in infected area of the nail

  12 months

• Number of study subjects with clinical cure

  12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental group: ABL01 is to be applied topically to the infected nail once a week during the study period to counter onychomycosis.

Device: ABL01

Control

PLACEBO COMPARATOR

Control group: Placebo solution to be applied topically to the infected nail once a week during the study period to counter onychomycosis.

Device: Placebo

Interventions

ABL01 DEVICE

Experimental medical device

Experimental

Placebo DEVICE

ABL01 lacking active component

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Men and women above age 18 weighing over 40 kg
• Present with distal lateral subungual onychomycosis of any of the big toe nails
• The onychomycosis should involve less than 50 % of the nail bed and may not have reached the cuticle

You may not qualify if:

• Unable to come for study visits
• Known allergy to any of the components in ABL01
• Not willing to participate in the trial or not able to understand the content of the trial
• Present with proximal subungual onychomycosis or superficial onychomycosis.
• Present with distal lateral subungual onychomycosis of other nails than the big toe.
• More than 50 % of the nailbed affected by onychomycosis or the cuticles infected
• Known conditions (like psoriasis) that cause abnormal nail appearance
• Nail damage caused by trauma, pressure or other mechanical reasons
• Currently on immunosuppressive therapy
• Showing signs of poor peripheral blood circulation
• Used another topical antifungal treatment within 1 month of screening
• Used a systemic antifungal treatment within 3 months of screening
• Participated in any other clinical onychomycosis trial in the previous 3 months

Sponsors & Collaborators

• Abbell AB: lead

Study Sites (1)

Fotcompaniet Stockholm

Stockholm, 113 52, Sweden

Location

Study Officials

• Irini Mouratidou-Kontorinis

  Fotcompaniet Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects are randomly assigned to treatment or placebo groups by a predetermined algoritm using sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind randomized controlled trail comparing ABL01 and placebo.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 5, 2017
• Study Start: August 14, 2017
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)